Nephrology
Conditions
Keywords
anemia, chronic kidney disease, CKD, hemodialysis, epoetin, Epogen®
Brief summary
The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
Interventions
DRUGEpoetin alfa RB
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
DRUGEpoetin alfa DT
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization
Exclusion criteria
- Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of weekly dose at the evaluation period to the weekly dose at baseline | Entire Study |
| Change in Heloglobin level between the screening period and the evaluation period | Entire Study |
Secondary
| Measure | Time frame |
|---|---|
| Average Epoetin alfa dose over evaluation period | evaluation period (weeks 21 - 28) |
| Change from baseline dose at each measurement timepoint | entire study |
| Epoetin alfa seroreactivity | entire study |
| Change from baseline Hb at each measurement timepoint | Entire Study |
| Hemoglobin variability | entire study |
| changes from baseline laboraotry and vital sign parameters | entire study |
| Subject incidence, nature and severity of adverse events | entire study |
| Maintaining Hemoglobin within range at each measurement timepoint | Entire Study |
Outcome results
None listed